Assessment of Contact Lens Wettability Using Wavefront Aberrometry

NCT02349438 | Completed Results

• 1 other identifier: CR-5685
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (3)

• Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking

  Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

  2 hours post insertion

• Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink

  Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

  2 hours post insertion

• Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink

  Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

  2 hours post insertion

Study Arms (2)

senofilcon A

EXPERIMENTAL

The lenses will be worn for 2 hours in both eyes, and not dispensed

Device: senofilcon A; Device: lotrafilcon B

lotrafilcon A

ACTIVE COMPARATOR

The lenses will be worn for 2 hours in both eyes, and not dispensed

Device: senofilcon A; Device: lotrafilcon B

Interventions

senofilcon A DEVICE

A soft spherical contact lens

lotrafilcon A; senofilcon A

lotrafilcon B DEVICE

lotrafilcon A; senofilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females that are at least 18 to no more than 40 years of age.
• The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
• The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
• The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
• Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
• The subject must have corrected visual acuity of 20/20 or better in each eye.

You may not qualify if:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
• Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
• Current wearers of rigid or hybrid contact lenses.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• History of binocular vision abnormality or strabismus.
• Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
• Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.
• Strabismus, suppression or amblyopia.
• Any ocular infection.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Kelvin Grove, Queensland, 4059, Australia

Location

Results Point of Contact

• Title: Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care Inc.

CColesb@ITS.JNJ.com

904-443-3449

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 28, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: January 20, 2017

Record last verified: 2016-11

Locations

AU (1)